The new cleanroom at our global headquarters in Salt Lake City, Utah, was designed for today's rigorous contamination control expectations, driven by EU GMP Annex 1. Learn More
In order to get reusable medical devices on the market, device manufacturers need to validate reprocessing instructions to ensure the device can be adequately cleaned, disinfected and sterilized.
An overview of the testing in ISO 10993-4: Selection of tests for interactions with blood and ISO 10993-3: Tests for genotoxicity, carcinogenicity and reproductive toxicity, specifically the hemocompatibility and when...
Most medical device manufacturers realize they need to have an environmental monitoring (EM) system within their facilities. The EM sets a count of microorganisms that are naturally in the environment....
Packaging Validations demonstrate the strength, integrity, and microbial barrier properties for porous and non-porous packages. These validations are required by FDA/ISO regulations before products can be sold. Nelson Labs has...
